Comparison of Virtual Reality-Based and Routine Preoperative Education on Surgical Anxiety and Salivary Cortisol

February 25, 2026 updated by: Bezmialem Vakif University

Comparative Evaluation of the Effect of Virtual Reality-Based Preoperative Education on Surgical Anxiety Using Psychometric Measures and Salivary Cortisol: A Randomized Controlled Pilot Trial

This randomized controlled pilot study aims to compare the effects of virtual reality-based preoperative education and routine preoperative education on surgical anxiety in patients undergoing lumbar disc surgery. In addition to evaluating psychological outcomes, the study will also compare psychometric anxiety assessments with a biological stress marker, salivary cortisol, to examine the relationship between subjective and physiological stress responses.

Preoperative anxiety is common among surgical patients and may negatively influence both emotional well-being and physiological stress regulation. Virtual reality-based education may provide a more immersive and engaging learning experience compared to routine education, potentially reducing anxiety levels.

Participants will be randomly assigned to either a virtual reality-based education group or a routine preoperative education group. Surgical anxiety will be assessed using validated psychometric measurement tools, and physiological stress response will be evaluated through salivary cortisol analysis. The study will further explore the concordance between psychometric findings and biological stress indicators.

The results may contribute to the development of innovative, evidence-based nursing interventions and provide insight into the relationship between psychological and biological indicators of preoperative anxiety.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled pilot trial is designed to evaluate the effectiveness of virtual reality-based preoperative education compared to routine preoperative education in adult patients scheduled for elective lumbar disc surgery. In addition to comparing anxiety levels between groups, the study aims to examine the relationship between psychometric assessments of surgical anxiety and the biological stress response measured by salivary cortisol.

Eligible participants will be adult patients undergoing elective lumbar disc surgery who meet the inclusion criteria and provide informed consent. Participants will be randomly allocated to one of two groups using a structured randomization process to ensure balanced distribution.

The intervention group will receive a structured virtual reality-based preoperative education session delivered through immersive technology explaining the surgical procedure, operating room environment, and perioperative process. The control group will receive routine preoperative education provided according to standard clinical practice. All participants will continue to receive standard medical and nursing care.

Data collection will be performed at predefined time points. Baseline measurements (T0) will be obtained prior to the educational intervention. Post-intervention anxiety assessments and salivary cortisol sampling (T1) will be conducted during the preoperative period before surgery. Surgical anxiety will be assessed using validated psychometric measurement instruments. Salivary cortisol levels will be analyzed as an objective indicator of physiological stress response.

The study will evaluate between-group differences in anxiety scores and cortisol levels. Additionally, the concordance and relationship between subjective psychometric measures and biological stress markers will be analyzed.

As a pilot study, the primary objectives include assessing feasibility, preliminary effectiveness, and methodological suitability for a future large-scale randomized trial. The findings may contribute to the development of evidence-based, technology-supported nursing interventions aimed at reducing preoperative anxiety and improving perioperative patient outcomes.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age between 18 and 65 years

Hospitalized patients scheduled for elective lumbar disc herniation surgery in the preoperative period

American Society of Anesthesiologists (ASA) physical status I-III

Able to read and understand Turkish and be literate

Sufficient cognitive capacity to understand the informed consent form (no advanced dementia, severe aphasia, impaired consciousness, or neurological/psychiatric condition interfering with communication)

Willing to complete the State Anxiety Inventory - State form (STAI-S) for surgical anxiety assessment and to provide a saliva sample using a non-invasive method

No severe visual impairment that would prevent the use of a virtual reality headset (visual impairments correctable with glasses or contact lenses are acceptable)

Provision of written and verbal informed consent

Exclusion Criteria:

Presence of an emergency or urgent neurosurgical indication (e.g., traumatic acute subdural hematoma, acute intracranial hemorrhage with herniation signs)

History of diagnosed epilepsy, particularly photosensitive epilepsy

Severe cognitive impairment, severe aphasia, lack of cooperation, or altered level of consciousness

History of psychiatric hospitalization within the last 6 months due to severe psychiatric disorders such as psychotic disorder, bipolar disorder, or severe major depressive disorder

Chronic systemic steroid use or endocrine disorders significantly affecting adrenal cortex function (e.g., Cushing syndrome, Addison's disease)

Untreated severe thyroid disease that may affect cortisol metabolism

History of severe vertigo or vestibular disorders with prior intolerance to VR-like visual stimuli

Severe visual impairment not correctable with glasses or contact lenses that would prevent adequate perception of VR content

Inability to complete the VR session due to nausea, dizziness, or similar symptoms during headset use (in such cases, the intervention will be discontinued and the participant will be withdrawn from the study)

Severe oral lesions, active serious oral infection, or significant salivary gland pathology interfering with saliva sampling

Known pregnancy or suspected pregnancy

Participation in another randomized controlled trial or VR-based intervention within the last 3 months

Withdrawal of consent during the study or cancellation/postponement of the scheduled surgical procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality-Based Preoperative Education
Participants in this arm receive virtual reality-based preoperative education using a head-mounted VR device on the day before lumbar disc surgery. The VR content provides structured information about the surgical process, operating room environment, anesthesia, and postoperative expectations. Psychological anxiety is assessed using validated psychometric scales, and salivary cortisol samples are collected to evaluate the physiological stress response.
Behavioral: Virtual Reality-Based Preoperative Education
Virtual reality-based structured preoperative education delivered via a head-mounted VR device before lumbar disc surgery.
Active Comparator: Routine Preoperative Education
Participants in this arm receive routine preoperative education provided according to the hospital's standard clinical practice before lumbar disc surgery. The education includes verbal information about the surgical procedure, anesthesia, and postoperative care. Psychological anxiety is assessed using validated psychometric scales, and salivary cortisol samples are collected to evaluate the physiological stress response.
Behavioral: Routine Preoperative Education
Standard verbal preoperative education provided according to hospital clinical practice before lumbar disc surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Surgical Anxiety Level (SAQ Total Score)
Time Frame: From T1 (morning of surgery, before education) to T2 (90-120 minutes before surgery, after education)
Change in preoperative anxiety measured by the Surgical Anxiety Questionnaire (SAQ) total score between baseline (T1, pre-intervention on the morning of surgery) and post-intervention assessment (T2, 90-120 minutes before surgery).
From T1 (morning of surgery, before education) to T2 (90-120 minutes before surgery, after education)
Change in Salivary Cortisol Level
Time Frame: From T1 (morning of surgery, before education) to T2 (90-120 minutes before surgery, after education)
Change in physiological stress response measured by salivary cortisol levels between baseline (T1, pre-intervention on the morning of surgery) and post-intervention assessment (T2, 90-120 minutes before surgery).
From T1 (morning of surgery, before education) to T2 (90-120 minutes before surgery, after education)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Principal Investigator: NURGÜL ARPAG, Assistant Professor,PhD, RN, Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Asiri S, Currie J, Duff J, Guilhermino M. Effectiveness of virtual reality interventions for perioperative anxiety in adults: A systematic review with meta-analysis. Journal of Clinical Nursing. 2025;34:3539-3559. Moharam SA, et al. Effect of virtual reality on perioperative anxiety, stress and pain in total hip arthroplasty: A randomized controlled trial. BMC Anesthesiology. 2025;25:446. Karamad SP, Elahi A, Tabari F, Haghani S, Dehghan MF, Navidhamidi M. Evaluating the effect of preoperative provision of information on salivary cortisol in patients undergoing breast cancer surgery: A randomized controlled study. Journal of PeriAnesthesia Nursing. 2023;38:63-68. Topçu SY, Soydaş D, Özkan ZK, Ünver S, Orğan EM, Fındık ÜY. Turkish validity and reliability study of the Surgical Anxiety Questionnaire for adult patients. Journal of PeriAnesthesia Nursing. 2023;38:127-133.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 27, 2026

Primary Completion (Estimated)

April 27, 2026

Study Completion (Estimated)

May 27, 2026

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BVU-20260206-VR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

At this stage, a final decision regarding the sharing of individual participant data (IPD) has not yet been made. Data sharing policies will be determined following study completion in accordance with institutional regulations, ethical approvals, and applicable data protection laws.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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